Sr Quality Specialist - Nonconformances CAPAs 525373
Sr Quality Specialist - Nonconformances CAPAs 525373
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$ 108026 - 135033
1 Vacancy
Job Description
Would you like to join an international team working to improve the future of healthcare Do you want to enhance the lives of millions of people Grifols is a global healthcare company that since 1909 has been working to improve the health and wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.
Grifols Diagnostic Solutions is seeking a Senior Quality Assurance Specialist. The Sr Quality Assurance Specialist manages nonconformances OutofTolerance Reports and CAPA records ensuring timely corrective actions and comprehensive documentation. They lead quality meetings represent QA in daily meetings and drive quality improvements through operational analysis and compliance audits. The role involves improving procedures conducting risk assessments preparing for audits managing metrics mentoring junior staff and developing training programs. Additionally they review and approve manufacturing documents lead projects make datadriven decisions facilitate training sessions and act as a backup to the department Supervisor/Manager.
To succeed in this role we are seeking individuals with at least a BA or BS in biology chemistry biochemistry or biomedical engineering (Quality certification (from American Society for Quality or equivalent) is a plus). Along with 58 years related quality experience relatable quality including nonconformances CAPAs compliance audits and OOT reports (with a Bachelors) or a masters degree with 36 years of experience.
Primary Responsibilities
- Independently conducts instrument related complaint investigation (nucleic acid testing) through interfacing with field reps. to acknowledge document and obtain detailed information/returns regarding complaints performing deeper investigation into root causes assigning additional actions as necessary to close the complaint performing data trending and preparing periodic reports relating to complaints and quality issues.
- Review/update/create SOPs to standardize the investigation process.
- Applies knowledge of medical device regulatory requirements to identify reportable events as they are received support the reporting decision process and coordinate Product Quality Committee meeting to determine appropriate plans for actions to be taken. Provide track and trending for PHSC.
- Leads crossfunctional teams from internal departments/outside vendors to establish appropriate processes for product quality improvements. Ensures implementation/sustainability and monitors the field quality of the improvements.
- Represents QA interests on special projects related to area of expertise.
- Coordinates regional meetings with field service engineers and field service representatives.
- Interacts with regulatory and partner auditors/inspectors.
Knowledge Skills and Abilities
- Advanced knowledge of complaint handling nucleic acid testing instrument (hardware and software) QC Manufacturing & Inventory processes
- Working knowledge of SAP/Salesforce Microsoft Word Excel (or other data trending/analysis tools) Power Point and related functions including the formulation of graphs.
- Organizational skills attention to detail and ability to prioritize in a fast paced environment is essential.
- Must demonstrate initiative independence balanced assertiveness flexibility and team orientation.
- Ability to train and mentor within and outside the group
Education
Requires BA or BS in biology chemistry biochemistry or biomedical engineering.
Quality certification (from American Society for Quality or equivalent) is a plus.
Experience
58 years related quality experience in complaint handling and investigation or a Masters degree with 36 years of experience.
Equivalency
Depending on the area of assignment directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelors degree plus 4 years of experience an equivalency could include 8 years of experience an Associates degree with 6 years of experience or a Masters degree with 2 years of experience.
PayScale
The estimated pay scale for the Senior Production Quality Associate role based in San Diego California is $108026.40 to $135033 per year. Additionally the position is eligible to participate in up to 8 of the company bonus pool. We offer a wide variety of benefits including but not limited to: Medical Dental Vision PTO up to 5 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education experience skillset knowledge where the role is performed internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909 Grifols has been a family company that prides itself on its familylike culture. Our company has more than tripled over the last 10 years and you can grow with us!
#LIDC
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants including those with arrests or conviction records in a manner consistent with the requirements of applicable state and local laws including the California Fair Chance Act the Los Angeles County Fair Chance Ordinance for Employers and City of Los Angeles Fair Chance Initiative for Hiring Ordinance.
Location:NORTH AMERICA : USA : CASan Diego:USSDW San Diego CA Willow Ct Mfg
Required Experience:
Senior IC
Employment Type
Full-Time
